A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where does the FDA, which got a late start with biosimilars, stand in terms of regulatory flexibility today?
This article will be part of the CPhI 2016 Annual Report, which will be released during the CPhI Worldwide event in Barcelona (October 4-6, 2016).
A company needs to be proactive and creative when building the case for its biosimilar to payers. In a recent conference panel, two experts from Express Scripts and Kaiser Permanente share their thoughts on four big questions you might have about biosimilar commercialization and adoption.
This article will explore a critical but often overlooked component of bioprocess facility design — HVAC systems — and the realities of HVAC compliance and methods. HVAC is the single continuous and active system that removes the bioburden and particulates introduced by the facilities’ single most contaminating source, humans!
There is a lot of pressure for companies to accelerate the clinical development of a biosimilar to make it to market before it becomes overcrowded. One challenge facing companies is comparator sourcing for their Phase 1 and Phase 3 trials. As one expert outlines, there are two different strategies, each presenting drugmakers with different benefits and challenges.
Last week, the Journal of Managed Care & Specialty Pharmacy (JMCP) published research revealing current pharmacist perceptions on biosimilar naming. A number of media resources have leapt on the findings of this study as indicative of a potential danger the naming system alone could cause. But I feel as though these results speak to a greater issue with interchangeability that is worth examining a little more closely.
This is the first in a series of articles on Six Sigma that will introduce you to this methodical, rigorous approach to process excellence, and share the author's experiences using the technique in the pharmaceutical industry.
A more aggressive clinical timeline for biosimilars can get a candidate to market more quickly. But it also becomes more difficult to ensure that clinical trial personnel running biosimilar trials clearly understand their roles and responsibilities, especially when it comes to maintaining a blind. There are several things for sponsors to consider in order to ensure the right people in the trial remain blinded.
In December 2014, Express Scripts stunned the pharmaceutical industry when it added AbbVie's Viekira Pak hep C treatment to its 2015 formulary instead of Gilead's Harvoni because of pricing. However, as Steve Miller, CMO of Express Scripts, discussed at the World Biosimilar Congress USA, competitive prices are just the beginning of the commercialization journey.
The recent introduction in Europe of biosimilar anti-tumor necrosis factor (anti-TNF) drugs has attracted considerable attention. Much of the commentary to date has centered on price, but price tells only part of the story. Structural and perceptual differences have led to considerable heterogeneity in the levels of discounting, access, and uptake throughout and even within European markets.
Compared to traditional antibody expression, where routine purification and analytical strategies have been established over the last few years, next-generation biologics have complex designs. If you are first in class or you have a very bespoke up- and downstream process, it also means you will have bigger hurdles to overcome when it comes to regulatory support and filing. At Lonza, these challenges are addressed with the GS™ expression platform.
No single strain or vector is capable of being the best expression option for all types of biopharmaceuticals. Experts from Lonza answers questions about the proprietary expression platforms the company has assembled to rapidly generate high-producing cell lines for biological candidates.
Proving therapeutic equivalence is an important step in the approval process for a biosimilar. The research needed is time, labor and resource intensive, making it critical to maximize the investment. UBC’s Clinical Development team is supporting a sponsor with a Phase IV study of a gastroenterology biosimilar. This late phase study has yielded three important lessons for biosimilar manufacturers.
The pharmaceutical industry is moving faster than ever before, continually evolving to meet the changing and growing needs of patients around the world. The industry must continue to adapt in order to meet the increasing demands for new medicines.
The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.
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